Cleared Traditional

K915756 - BIOTRACK CARBAMAZEPINE TEST CARTRIDGE

K915756 is an FDA 510(k) clearance for BIOTRACK CARBAMAZEPINE TEST CARTRIDGE, manufactured by Biotrack, Inc.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K915756 · Biotrack, Inc. · Toxicology device
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Jul 1992
Decision
213d
Days
Class 2
Risk

K915756 is an FDA 510(k) clearance for the BIOTRACK CARBAMAZEPINE TEST CARTRIDGE. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 213 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotrack, Inc. devices

FDA 510(k) Submission Details - K915756

510(k) Number K915756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date July 23, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 53
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K915756.
QMS CARBAMAZEPINE ASSAY
K940374 · Seradyn, Inc. · Jun 1994
IL TEST CARBAMAZEPHINE
K933684 · Instrumentation Laboratory CO · Oct 1993
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI
K926441 · Roche Diagnostic Systems, Inc. · May 1993
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · Microgenics Corp. · Jan 1992
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · Boehringer Mannheim Corp. · Mar 1990